
Sr. Specialist, Post Market Quality
We are seeking an experienced and highly motivated Sr. Specialist, Post Market Quality to join the team at Becton Dickinson. This role requires an individual with excellent problem-solving skills, attention to detail, and the ability to thrive in a fast-paced environment. The ideal candidate will be an experienced professional with a minimum of 5 years of post-market quality experience in the medical device industry with knowledge of ISO 13485 and 21 CFR Part 820 regulations. The Sr. Specialist, Post Market Quality will play an essential role in ensuring the quality of our products, and we are looking for an individual who is passionate about quality and customer satisfaction.
Responsibilities:
- Maintain and develop post-market quality standards in compliance with ISO 13485 and 21 CFR Part 820 regulations.
- Monitor and investigate customer complaints, product returns, and field actions.
- Develop and implement corrective and preventive action plans to ensure continuous product quality improvement.
- Prepare post-market quality reports and communicate quality issues to management.
- Drive continuous improvement initiatives to ensure customer satisfaction.
- Develop post-market quality training and education materials.
- Develop and maintain strong relationships with internal and external stakeholders.
- Stay up-to-date with the latest medical device regulations and industry trends.
- Participate in internal audits and external customer audits.
- Identify process and system weaknesses and recommend improvement activities.
Ability To Work Independently And As Part Of A Team
Project Management Experience
Iso
Strong Problem Solving And Analytical Skills
Experience In Medical Device/Ivd Industry
Working Knowledge Of Fda Quality System Regulation (Qsr)
Working Knowledge Of Risk Management Principles
Good Understanding Of Statistics And Sampling Principles
Ability To Communicate Effectively With All Levels Of The Organization
Documentation
Quality Assurance
Troubleshooting
Data Analysis
Quality
Auditing
Technical Writing
Reporting
Compliance
Post Market Surveillance
Risk assessment
Analytical
Manufacturing
Regulatory
Systems
Communication
Leadership
Time management
Interpersonal Skills
Organization
self-motivation
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Sr. Specialist, Post Market Quality in San Diego, CA, USA is $78,000 to $114,000. This salary range may vary depending on the job duties, experience, and qualifications of the candidate. Additionally, the salary range may be affected by the industry, company, and location of the position.
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The BD Life Sciences segment delivers innovative solutions from discovery to diagnosis, continually advancing science and clinical outcomes across infectious disease and cancer. Offerings include preanalytical solutions for sample management, immunology research solutions, including flow cytometry and multiomics tools, microbiology and molecular diagnostics, lab automation and informatics solutions, as well as differentiated reagents and assays.

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